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Набор скоро начнётся NCT07729410

Eccentric Exercise Rehabilitation After Myocardial Infarction

Без фазы С лечением Myocardial Infarction (MI) Cardiac Rehabilitation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Standard Inpatient Cardiac Rehabilitation, Eccentric Cycling Exercise.
Кому может быть актуально
Состояния в реестре: Myocardial Infarction (MI), Cardiac Rehabilitation. Базовые параметры: 50 лет — 75 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Польша
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effects of Two-Week Eccentric Exercise-Based Cardiac Rehabilitation on Myokines, Exerkines, and Physical Function in Patients After Myocardial Infarction

Обзор

This clinical trial will evaluate a two-week eccentric exercise program conducted as part of comprehensive cardiac rehabilitation in patients after a heart attack (myocardial infarction). Eccentric exercise involves muscle contractions while the muscles are lengthening and may allow the muscles to work at a relatively high load with a lower cardiovascular and metabolic demand than traditional exercise. The main aim of the study is to determine whether eccentric exercise affects blood levels of proteins released or regulated in response to physical activity, including musclin, interleukin-6, and myostatin. The study will also evaluate whether the program improves physical performance and functional capacity. Participants will complete eccentric cycling exercise on a semi-recumbent cycle ergometer during a two-week cardiac rehabilitation program. Blood samples and physical-function measurements will be collected before and after the intervention.

Подробное описание

Exercise-based cardiac rehabilitation is an important component of secondary prevention after myocardial infarction. However, some patients experience reduced exercise tolerance or fear of physical activity, which may limit participation in rehabilitation and contribute to physical deconditioning, loss of muscle mass, and reduced functional capacity.

Eccentric exercise is characterized by muscle contractions performed while the muscle is lengthening. Compared with traditional concentric exercise, eccentric exercise can provide a relatively high mechanical load to skeletal muscles while requiring lower oxygen consumption and imposing a lower metabolic demand. For this reason, eccentric training may be a useful rehabilitation strategy for patients who have limited exercise tolerance after myocardial infarction.

The intervention will consist of a two-week eccentric cycling program performed on a semi-recumbent cycle ergometer as part of comprehensive cardiac rehabilitation. The training is intended to provide controlled loading of the lower-limb muscles while limiting excessive cardiovascular strain.

The primary scientific objective is to evaluate changes in the molecular response to eccentric exercise, with particular emphasis on circulating myokines and exerkines. Blood concentrations of musclin, interleukin-6, and myostatin will be assessed before and after the rehabilitation period. The study will also evaluate changes in physical performance, muscle function, and functional exercise capacity using the assessments specified in the study protocol.

The findings may help determine whether eccentric exercise produces beneficial molecular and functional adaptations in patients undergoing cardiac rehabilitation after myocardial infarction.

Вмешательства

  • Поведенческое Standard Inpatient Cardiac Rehabilitation
    Standard stage I inpatient cardiac rehabilitation provided after myocardial infarction and individualized according to each participant's clinical condition and exercise capacity. The program includes standard kinesitherapy and exercise-based rehabilitation procedures.
  • Поведенческое Eccentric Cycling Exercise
    Supervised eccentric cycling exercise performed on a motor-driven semi-recumbent cycle ergometer in addition to standard inpatient cardiac rehabilitation. Sessions will last 10 to 30 minutes, with progressive adaptation during the first five sessions. Exercise workload will be individualized according to baseline exercise capacity. Perceived exertion and muscle soreness will be monitored during each session.

Первичные конечные точки

  • Change From Baseline in Serum Musclin Concentration [Срок оценки: Baseline and after completion of the 2-week inpatient cardiac rehabilitation program]
  • Change From Baseline in Serum Myostatin Concentration [Срок оценки: Baseline and after completion of the 2-week inpatient cardiac rehabilitation program]
  • Change From Baseline in Serum Interleukin-6 Concentration [Срок оценки: Baseline and after completion of the 2-week inpatient cardiac rehabilitation program]
Вторичные конечные точки (4)
  • Change From Baseline in Six-Minute Walk Distance [Срок оценки: Baseline, before initiation of the inpatient cardiac rehabilitation program, and after completion of the 2-week intervention]
  • 30-Second Chair-Stand Test [Срок оценки: Baseline, before initiation of the inpatient cardiac rehabilitation program, and after completion of the 2-week intervention]
  • Change From Baseline in Kinesiophobia Assessed Using the Tampa Scale for Kinesiophobia Heart [Срок оценки: Baseline, before initiation of the inpatient cardiac rehabilitation program, and after completion of the 2-week intervention]
  • Change From Baseline in Peak Force During the Isometric Mid-Thigh Pull Test [Срок оценки: Baseline, before initiation of the inpatient cardiac rehabilitation program, and after completion of the 2-week intervention]

Критерии участия

Критерии включения

  • Documented history of myocardial infarction confirmed by medical records.
  • Qualification for stage I comprehensive inpatient cardiac rehabilitation.
  • Clinically stable condition allowing participation in exercise-based cardiac rehabilitation.
  • New York Heart Association functional class I or II.
  • Moderate or good exercise tolerance, defined as an exercise capacity of at least 5 metabolic equivalents, assessed during an exercise test.
  • No cardiovascular contraindications to exercise testing or participation in exercise-based cardiac rehabilitation.
  • Ability to understand the study procedures and follow the instructions provided by the study personnel.
  • Provision of written informed consent to participate in the study.

Критерии исключения

  • Any contraindication to exercise-based cardiac rehabilitation or exercise testing.
  • Acute myocardial infarction within the first 4 days before planned initiation of exercise rehabilitation.
  • Unstable angina.
  • Significant left main coronary artery stenosis considered a contraindication to exercise by the treating cardiologist.
  • Symptomatic cardiac arrhythmias.
  • Symptomatic severe aortic stenosis.
  • Decompensated heart failure.
  • Acute pulmonary embolism or pulmonary infarction.
  • Deep vein thrombosis.
  • Recent or mobile intracardiac thrombus.
  • Acute myocarditis, endocarditis, or pericarditis.
  • Aortic dissection.
  • Symptomatic acquired second- or third-degree atrioventricular block without appropriate cardiac pacing.
  • Poorly controlled arterial hypertension.
  • Recent stroke or transient cerebral ischemic event.
  • Any acute or uncontrolled non-cardiovascular condition that may interfere with exercise testing or worsen during exercise, including febrile illness, clinically significant electrolyte abnormalities, uncontrolled hyperthyroidism, or clinically significant anemia.
  • Physical or cognitive impairment preventing safe completion of the study procedures, exercise testing, or training intervention.
  • Inability or unwillingness to provide written informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Польша · 1 центр
  • Florian Ceynowa Specialist Hospital in Wejherowo — Wejherowo

Идентификаторы

NCT: NCT07729410 · GUMED-ECC-MI-001 · KB/359/2026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗